Booster Dose Study to Assess the Safety and Immunogenicity of ACM-001 Administered Intramuscularly or Intranasally.
An Open Label, Randomized, Dose and Route of Administration Comparison Phase 1 Study to Evaluate the Safety and Immunogenicity of the ACM-SARS-CoV-2-beta With ACM-CpG Vaccine Candidate (ACM-001), Administered Intramuscularly or Intranasally as a Booster Dose in Healthy Adults Aged 18 to 55 Years, Who Were Previously Vaccinated Against SARS-CoV-2.
1 other identifier
interventional
38
1 country
6
Brief Summary
An open label, randomized, dose comparison, sequential cohorts study design in healthy volunteers (young adults) is a frequently used design in vaccine Phase 1 studies. ACM-001 is developed as a booster vaccine against SARS-CoV-2 after a full primary vaccination with or without 1-2 booster doses (2 or 3 or 4 doses) schedule with any registered and commercial SARS-CoV-2 vaccines. The plan is to start with a low dosage of antigen alone, followed by a combination of antigen and adjuvant and then to progress to higher dosages to define the safety profile of the candidate vaccine as primary endpoint, and its immunogenicity as secondary endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2022
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 23, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2023
CompletedOctober 24, 2023
April 1, 2023
12 months
May 17, 2022
October 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Adverses events
Frequency, duration and intensity of solicited local AEs reported during 7 days following vaccination: injection site pain, erythema/redness (including size), and swelling/induration (including size) after IM injection, or nose pain, ear pain, runny nose, sneezing, stuffy nose and throat pain after IN administration.
through study completion, an average of 6 months
Secondary Outcomes (1)
Immune responses
through study completion, an average of 6 months
Study Arms (8)
SARS-CoV-2 beta S vaccine arm 1
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IM
SARS-CoV-2 beta S vaccine arm 2
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, no adjuvant, IN
SARS-CoV-2 beta S vaccine arm 3
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IM
SARS-CoV-2 beta S vaccine arm 4
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 2, adjuvant dose 1, IN
SARS-CoV-2 beta S vaccine arm 5
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IM
SARS-CoV-2 beta S vaccine arm 6
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 1, IN
SARS-CoV-2 beta S vaccine arm 7
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IM
SARS-CoV-2 beta S vaccine arm 8
EXPERIMENTALSARS-CoV-2 beta S vaccine Antigen dose 1, adjuvant dose 2, IN
Interventions
ACM-SARS-CoV-2-beta ACM-CpG vaccine candidate (ACM-001): Artificial Cell Membranes (ACM) containing recombinant SARS-CoV-2, beta- variant strain, spike protein and ACMs containing CpG adjuvant
Eligibility Criteria
You may qualify if:
- Signed informed consent prior to any study-related procedure;
- Subjects must have received a complete primary vaccination schedule and a third and/or fourth booster dose with registered and commercial vaccine(s) against SARS-CoV-2, of which the last dose was given at least 3 months prior to study vaccination (maximum of 1,000 IU of anti-S IgG);
- Healthy males and females, 18-55 years of age, inclusive at screening;
- Body mass index (BMI) ≥ 18.0 and \< 30.0 kg/m2;
- Good health, based upon the results of medical history, physical examination, vital signs, laboratory profiles of both blood and urine, and according to the clinical judgement of the investigator;
- Female participants of childbearing potential must be willing to comply with effective contraception up to 90 days after the study vaccine administration;
- Willing to comply with the study procedures.
You may not qualify if:
- DocuSign Envelope ID: C34D91C3-4686-427D-BB78-CF7178216E74 Endpoints 21. Close contact with laboratory-confirmed COVID-19 cases within 10 days prior to vaccination, high risk of exposure or has an occupation with a high risk of exposure to SARS-CoV-2 (emergency response); 22. Pregnancy confirmed by a positive pregnancy test, lactation or intention to become pregnant during the study; 23. Any cancer diagnosed and/or treated within the past 5 years (except basal cell carcinoma of the skin and cervical carcinoma in situ); 24. Veins not suitable for repeated blood sampling; 25. Serious reaction, such as anaphylactic reaction, following primary COVID-19 vaccination; 26. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results; 27. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted, including children of newly composed families.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ACM Biolabslead
Study Sites (6)
Paratus Research Central Coast
Kanwal, New South Wales, 2259, Australia
Paratus Research Sydney
Sydney, New South Wales, Australia
Paratus research Brisbane
Brisbane, Queensland, 4010, Australia
Paratus research Canberra
Canberra, ACT 2617, Australia
Emeritus Research Melbourne
Melbourne, Australia
Emeritus Research Sydney
Sydney, Australia
Related Publications (3)
Dress RJ, Ho WW, Ho V, Lam JH, Decaillot FM, Sinsinbar G, Soo J, Rengasamy G, Khan AK, Cornell TA, Chia TW, Venkataraman S, Nallani M, Ginhoux F. A Novel Polymersome Nanocarrier Promotes Anti-Tumour Immunity by Improved Priming of CD8 + T Cells. Immunology. 2025 May;175(1):21-35. doi: 10.1111/imm.13903. Epub 2025 Jan 28.
PMID: 39873184DERIVEDNakahashi-Ouchida R, Fujihashi K, Kurashima Y, Yuki Y, Kiyono H. Nasal vaccines: solutions for respiratory infectious diseases. Trends Mol Med. 2023 Feb;29(2):124-140. doi: 10.1016/j.molmed.2022.10.009. Epub 2022 Nov 23.
PMID: 36435633DERIVEDLam JH, Shivhare D, Chia TW, Chew SL, Sinsinbar G, Aw TY, Wong S, Venkataraman S, Lim FWI, Vandepapeliere P, Nallani M. Artificial Cell Membrane Polymersome-Based Intranasal Beta Spike Formulation as a Second Generation Covid-19 Vaccine. ACS Nano. 2022 Oct 25;16(10):16757-16775. doi: 10.1021/acsnano.2c06350. Epub 2022 Oct 12.
PMID: 36223228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 23, 2022
Study Start
July 1, 2022
Primary Completion
June 30, 2023
Study Completion
August 22, 2023
Last Updated
October 24, 2023
Record last verified: 2023-04